Clinical Research Project Manager B/C (OBGYN - Pregnancy and Perinatal Research Center) at The University of Pennsylvania in HUP

Job description

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Project Manager B/C (OBGYN - Pregnancy and Perinatal Research Center) Job Profile Title Clinical Research Project Manager B Job Description Summary This position will support funded research projects for the Pregnancy & Perinatal Research Center under supervision of the Director of Clinical Research Operations. The primary role of this position is the organization, coordination, and implementation of multiple clinical research studies. Job Description Job Responsibilities Clinical Research Project Manager B The essential functions of the position include but are not limited to: Develop study workflows and coordinate participant visits, testing, and appointment coverage in accordance with study protocols and Good Clinical Practice (GCP) guidelines. Provide operational oversight for one or more large-scale clinical research studies, including the creation and maintenance of study logs, calendars, and tracking tools to support recruitment, retention, and study milestones. Lead implementation of new and existing study protocols, including developing operational plans and training research staff on study procedures and integration into existing workflows. Design, develop, and maintain case report forms (CRFs) and databases in REDCap; train research staff on proper data collection and documentation procedures. Monitor data quality, completeness, and timeliness; identify and resolve data discrepancies; provide real-time feedback and training to research staff to ensure compliance with study and sponsor requirements. Prepare and submit regulatory documents, including protocol modifications, deviations, continuing reviews, and other Institutional Review Board (IRB) submissions. Train and mentor research staff on regulatory processes and IRB submission requirements, as appropriate. Supervise assigned research personnel, including performance management, completion of annual evaluations, approval of leave requests, onboarding, training, and professional development. Collaborate with other project managers to ensure consistent performance expectations and effective cross-coverage among research staff. Partner with clinical and operational staff to facilitate the seamless integration of research activities into clinical operations. Other duties assigned as needed. Clinical Research Project Manager C The Project Manager C, in addition to the responsibilities mentioned above will also perform these duties: Collaborate with PPRC leadership to develop, implement, and maintain center-wide Standard Operating Procedures (SOPs) that promote con